When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to azficel-T, amphotericin, gentamicin, dimethyl sulfoxide (DMSO), or any products made from cattle (bovine). Do not use this medicine if you have a skin infection on your face.

How to Use This Medicine:
Injectable

• Your doctor will take 3 small skin samples from behind your ears and send them to the manufacturer. Certain cells are grown from these samples for 3 to 6 months and shipped back to your doctor.
• A doctor will give you this medicine in a hospital or clinic. This medicine is given through a small needle placed into your wrinkles. This medicine is usually given in 3 treatments about 3 to 6 weeks apart.
• After treatment with this medicine:
  
  • Apply a cold compress for 2 to 3 minutes at a time to ease swelling or discomfort. Do not apply ice directly to your face.
  • Do not wash the injection site for at least 24 hours.
  • Do not rub, scrub, or massage the injection site for at least 72 hours.
  • Do not apply any cosmetic products (such as make-up, facial creams, or sunscreen) to the treatment area for 72 hours.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a treatment, your medicine may not be usable. You must work with your doctor to reschedule your treatment session.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how azficel-T works. Tell your doctor if you are taking any of the following:
  
  • Aspirin
  • Blood thinner medicine, such as warfarin
  • Medicines that weaken the immune system, such as cancer medicine
  • NSAID pain or arthritis medicine, such as celecoxib, ibuprofen, naproxen, rofecoxib, valdecoxib

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, blood vessel disorder (such as vasculitis), cold sores, genetic disorders of the skin, immune system problems, or a history of skin cancer, keloids, or excessive scarring.
• This medicine may increase your risk for the following problems:
  
  • Basal cell cancer
  • Bleeding or bruising at the injection site
  • Herpes labialis
  • Vasculitis
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding, bruising, pain, swelling, itching, blistering, or lumps where the shot was given
• Fever over 100 degrees F
• Painful cold sores
• Redness, warmth, or pain at the injection site lasting for more than 3 days
• Swelling of the face or eyelids

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088